The present invention relates generally to a cover or barrier to prevent cross-infection. In particular, the present invention relates to a range of anti-fomitic covers to prevent cross-infection, including such covers for pillows, mattresses, X-ray cassettes, surgical and diagnostic equipment, toilet seats, table and chair seat surfaces, wash basin faucet handles and other handles, etc., as well as covers such as diapers or other similar sorts of xe2x80x9cclothing,xe2x80x9d for example, surgical robes, shoe covers for the surgical room, etc.
The problems of cross-infection and the production of antibiotic-resistant mutations have been subjects for concern in hospital settings, as well as in household and other settings, such as the hospitality industry (hotels, motels, bed and breakfast businesses, hostels, etc.). These problems are particularly problematic for those with compromised immune systems or with special bacterial, viral, fungal, parasitic, or other susceptibilities. The latter category of special susceptibilities may also include persons with allergies, and persons who develop one or more of a range of contact dermatitises, to name but a few non-limiting examples.
One means of transmitting bacteria, viruses, fungi, and other pathogens is by fomites, which are inanimate agents of such transmissions, including, for example, bedding, toilet seats, clothes, table tops and other fixed surfaces, surgical and X-ray equipment, etc. Thus, a fomite (also called a fomes) may absorb or otherwise harbor one or more strains of pathogenic bacteria, fungi, viruses, etc., and later transmit those pathogens, by contact, to a human.
A common fomite found in hospitals is metallic X-ray cassettes. Both patients and hospital staff may handle or otherwise touch an X-ray cassette, depending on the X-ray system used and the particular application. For example, in some applications, an undraped patient may hold an X-ray cassette in position against a portion of his body during X-ray filming. Subsequent to the filming, one or more hospital staff members may also touch the X-ray cassette during the progression culminating in photographic development of the X-ray film.
Another common fomite is bedding, where commonly employed materials, such as cotton, act as wicks to carry pathogens far from the initial contact point with human skin, particularly when moisture is present (sweat, semen, saliva, vaginal secretions, secretions from wounds and open pimples, spilled drinks, etc.). Thus, when sheets and pillow cases are changed, the deeper lying material (mattress, mattress cover, pillow) still harbors potential pathogens of the previous user(s). Furthermore, the next userxe2x80x94particularly when moisture is introduced onto the xe2x80x9cscenexe2x80x9dxe2x80x94can become infected by reverse wicking; i.e., moisture can draw deep lying pathogens back toward the surface of the bedding that is in contact with the user.
Similar to bedding, clothing and related items (such as diapers, surgical robes and covers) also are subject to the problem of passing pathogens from the person wearing the item to another person or surface into which the item comes into contact. Again, as with bedding, the problem of cross-contamination is exacerbated by wicking in the presence of moisture.
Another common fomite is the surfaces encountered in bathrooms. As has been well documented for decades, toilet seats, the faucet handles of wash basins, door handles, etc., and other surfaces in bathrooms are commonly contaminated with E. coli and other pathogens. As but one illustration of the problem, one need only recognize that a user of a toilet often will leave the toilet with substantial E. coli contamination of at least one hand. That individual may then, in turn, contaminate the knob/handle of the toilet stall, and then one or more faucet handles at a wash basin. Said individual then washes his hands, but touches the one or more faucet handles that he had just contaminated in the process of turning off the water flow, thereby re-contaminating his hand(s). Thus, whatever is subsequently touched by the E. coli-contaminated hand(s) of that individual will also become so contaminated.
As another example of cross-contamination in the bathroom setting, pathogens on toilet seats may be transmittable to the next user. One such example is the herpes viruses, which may be transmitted to a subsequent contactor, particularly if that individual has an open wound. Other pathogens may similarly be so transmitted, though some will require relatively immediate contact by the next person when the pathogen is not hardy outside a xe2x80x9cbiologicalxe2x80x9d setting (i.e., a setting having the requisite moisture and/or temperature close to human interior body temperature).
Yet another setting that is ripe for cross-contamination is the kitchen. Not only is there the well documented potential problems with contamination sources such as chicken skin (Salmonella, etc.), raw beef (E. coli, etc.), and insects and other bugs and parts thereof (keeping in mind that the FDA allows such contamination to prescribed levels), but also E. coli contamination due to the use of toilets by the kitchen worker (or from contamination by a previous user of the toilet). In the same manner noted above in the context of bathrooms, cross-contamination of faucet handles of wash basins/sinks in kitchens is wide spread. The kitchen cross-contamination problem may also be extended to include problems from the use of cutting boards (problematic particularly with porous material like wood) and from inadequate cooking of contaminated food. In addition, inadequate cleaning of virtually all kitchen surfaces into which human skin comes into contact, directly or indirectly, further compounds the problem of cross-contamination; and this would include not only faucet handles, but also table, counter and other surfaces, as well as handles to ovens, refrigerators, microwave units, etc.
One study of hospitals (Surgical Clinics of North America 50 [No. 4]: pages 945-952, August 1970) included analysis of portions of X-ray rooms and X-ray equipment, including cassettes used in portable X-ray machines. Organisms cultured from these cassettes included staphylococcus aureus (coagulase negative), staphylococcus aureus (coagulase positive), streptococcus viridans, aspergillus, fungus, and diptheroids. The cassettes cultured in this study included ones placed in direct contact with undraped patients.
U.S. Pat. No. 3,092,252 to Brause, et al. discloses packages with folds at one end for use in protecting humans from pathogens that otherwise might be present on thermometers, tongue depressors, surgical instruments, fingers/hands, etc. The inner surface of the packages of this invention initially are sterile, though the objects placed within the packaging are not sterile. Multiple folds are utilized in the practice of this invention. Complicated folding is utilized in the packaging of this invention.
U.S. Pat. No. 3,215,265 to Welin-Berger discloses the use of a plurality of sheaths to protect patients from cross-contamination from thermometers. An inner package covers a thermometer, and may remain about the thermometer during insertion into a body orifice for temperature measurement. An outer package contains the inner package along with its contents.
U.S. Pat. No. 3,847,280 to Poncy discloses a sterile package for clinical thermometers and similar diagnostic equipment elements, where packaging may be stripped from sheathing surrounding the thermometer or other diagnostic equipment elements. Multiple layers and coatings are used, including ones for lubricants. One embodiment utilizes a plurality of packages that are attached in succession and separated by perforated sections for convenient separation.
U.S. Pat. Nos. 3,941,245 and 3,988,873 to Oliveriuis disclose the use of flexible, multi-layered containers, including a first container that slides within a second container, for containing and securing contaminated articles.
U.S. Pat. No. 4,057,731 to Loseff discloses a sterile container for X-ray cassette holders that also includes means for securing it to the body portion being X-rayed, i.e., straps and pressure-sensitive adhesives. In addition, a transparent wind is available, through which the internally located X-ray cassette maybe visualized. A flap/cuff may be used at the mouth of the container.
U.S. Pat. No. 4,445,241 to Ender, et al. discloses an air tight, multi-layered cover for pillows, mattresses and other padded objects. A complicated series of filters is disposed between compartments therein.
U.S. Pat. No. 4,770,911 to Sengewald discloses a cover for surrounding an operating table surface. Basically, a hose is closed at one end, and pulled over a cantilevered table surface, for example.
U.S. Pat. No. 4,902,453 to Ernst discloses a disposable envelope for enclosing an X-ray cassette designed to retard or prevent the spread of infections to or from the patient. Two sheets each of two layers (polyethylene inner layer; polyester outer layer) are heat sealed on three sides to form a pocket.
U.S. Pat. No. 4,923,453 to Bullard, Jr. discloses a disposable cover for use on X-ray and other similar tables used in medical settings. A three-layer construction is used, the middle layer of which is a fluid absorbent layer.
U.S. Pat. No. 5,050,256 to Woodcock discloses a bedding cover system designed for use in situations in which allergies to mites are problematic. Materials are used that are permeable to water but constitute barriers to mites, for example, by using pores generally less than 10 microns. Applications include use as mattress covers and as pillow covers.
U.S. Pat. No. 5,123,535 to Patnode. et al. discloses a flexible sterile bag for covering an X-ray cassette. Pressure-sensitive adhesive coatings on opposing end cuff portions permit ready closure of the bag by pressing the two cuffs together.
U.S. Pat. No. 5,228,851 to Burton discloses a protective sleeve that is designed to be placed on the handle of a medical or dental instrument to prevent the transmission of bacteria, etc., from one patient to another.
U.S. Pat. No. 5,343,861 to Herman discloses a disposable tonometer cover and packaging method designed to prevent infection in tonometry eye testing. A receptacle in the general shape of the applanation tip is used to directly contact the eye to determine the internal pressure thereof, and a peal-away cover is also incorporated.
U.S. Pat. No. 5,365,023 to Lawton discloses an elastic latex, disk-shaped cover for fitting over various stethoscope heads.
U.S. Pat. No. 5,446,897 to Ross. et al. discloses a dispenser apparatus for dispensing disposable stethoscope diaphragms. The apparatus is designed to prevent the spread of infections.
U.S. Pat. No. 5,541,972 to Anthony discloses a padded, sterile covering that fits over the face and about the edges of an X-ray plate that is used for mammography.
U.S. Pat. No. 5,554,098 to Yabe, et al. discloses a disposable protection cover for the tip of an endoscope, as well as a separate cover for other sections of the endoscope.
U.S. Pat. No. 5,564,431 to Seward discloses a flexible stethoscope cover and dispensing/packaging system for the head of a stethoscope. The cover basically is a rolled tube that is unrolled to cover a stethoscope head, much in the manner that a condom is applied.
U.S. Pat. No. 5,566,410 to Schaechter discloses a pillow cover that is designed for quick sealing by a hook-and-loop closure (Velcro(trademark), for example). Other than the sealing means, the pillow cover is conventional.
U.S. Pat. No. 5,599,093 to Hoftman, et al. discloses a disposable combination light cover and handle for use with a conventional operating room light fixture to prevent the spread of infectious agents. The cover/handle basically consists of a closed-end tube that fits over a rod-like handle on a surgical light fixture, plus an annular flange/lip about the open end of the cover/handle.
In the realm of X-ray cassettes and similar medical and dental devices that come in direct contact with healthcare workers and patients, as well as in the realm of items common to the household and to the hospitality industry, a need exists for disposable covers that include a simple constellation of features not all available in any one or any combination of the above-cited disclosures. The covers must be simple in construction (ideally including only a single layer, but possibly including two or more layers), and capable of easy and inexpensive production. The covers must be disposable. The covers must be transparent to X-rays if the object being covered is an X-ray cassette or other X-ray recording device. The covers must not permit the passage of bacteria and other disease causing organisms (pathogens) to pass from one side to the other. For example, organisms on an X-ray cassette must not be able to come in contact with a patient or healthcare worker, and, likewise, organisms on or in a patient or healthcare worker must not be able to penetrate the covers and thereby contaminate the X-ray cassettes or other medical devices protected by the covers. With respect to bedding and other applications (e.g., covers for equipment, faucet handles and other handles, etc.), the covers similarly must not permit the passage of pathogens from one side of the covers to the other. The covers must also be non-reactive with typical human skin so as not to produce irritation or contact dermatitis. The covers must be capable of easy and quick application for covering the desired object. Finally, the covers must be easily sealable or attachable, where applicable; and, where the application requires adhesive contact with human skin, the adhesive must not irritate the skin, or produce a contact dermatitis.
The series of embodiments of the present invention achieve a variety of results and applications. Thus, it is an object of the present invention to provide a disposable, sealable bag or envelope structure for encasing an X-ray cassette or other X-ray recording device, surgical instrument, or diagnostic instrument, bedding, table or chair seat surface, faucet handle or other handle, etc., in a way that prevents the spread of bacteria and other pathogens among multiple persons using the same object.
It is another object of the present invention to provide multiple, optional, closure/sealing methods for a disposable bag or envelope structure for encasing an X-ray cassette or other X-ray recording device, surgical instrument or diagnostic instrument, bedding, table or chair seat surface, faucet handle or other handle, etc., including but not limited to adhesive (including, for example, adhesive strips that are covered with a protective sheet when not in use), heat sealing, hook-and-loop structures (for example, Velcro(trademark)), Ziplock(trademark), and tucked flaps.
It is another object of the present invention to provide a disposable, sealable bag for encasing an X-ray cassette or other X-ray recording device, surgical instrument or diagnostic equipment, bedding, table or chair seat surface, faucet handle or other handle, etc., where the opening of the bag incorporates a slit at one or more edges to facilitate entry and positioning of the object therein.
It is yet another object of the present invention to provide a disposable flat sheet for covering the front of an X-ray cassette or other X-ray recording device, surgical instrument or diagnostic instrument, bedding, table or chair seat surface, toilet seat, faucet handle or other handle, etc., by merely folding ends over to attach by adhesive to the back of an object.
It is yet another object of the present invention to provide a disposable bag structure for covering an X-ray cassette or other X-ray recording device, surgical instrument or diagnostic instrument, table or chair seat surface, faucet handle or other handle, bedding, etc., where the disposable bag structure is part of a continuous structure of end-to-end bags that may be stored in rolled form, and with perforations or other scoring between adjacent bags to facilitate their separation when ready for use.
It is yet another object of the present invention to provide a disposable, sealable bag that (prior to use) is folded back upon itself such that, when in use, the previously internal, sterile, folded-over bag surfaces become the external surfaces against which the skin of the patient or other person comes in contact. Such back-folded bags are intended for a broad range of applications, such as for X-ray cassettes, thermometers, pillows, mattresses, and surgical, diagnostic and other instruments, table or chair seat surface, faucet handle or other handle, etc.
It is yet another object of the present invention to provide a disposable bag for covering the front of an X-ray cassette or other X-ray recording device, or other surgical or diagnostic instrument by providing xe2x80x9cend pocketsxe2x80x9d at each end of a flat sheet. Thus, the front surface of the object is covered, as well as the back surface at each end to the extent of the depth of the two xe2x80x9cend pockets.xe2x80x9d
The present invention overcomes limitations in the prior art by providing a series of embodiments for covers for X-ray cassettes or other X-ray recording devices, surgical or diagnostic or other instruments, bedding, faucet handles or other handles, table or chair seat surface, toilet seats, etc., that will prevent or at least greatly minimize the transmission and cross-infection of bacteria and other pathogens from patient to patient, from patient to healthcare worker, from healthcare worker to patient, etc. The covers may be made of any disposable material that is transparent to X-rays and also impervious to bacteria and other pathogens, such as non-woven cellulosic derivatives, including any of the huge array of plastics suitable for use against human skin, such as polyvinyl chloride (including homopolymers and copolymers thereof), polyesters, polyolefins, and other polymers.
In one embodiment, a flat bag is provided with an open end (optionally including one or more slits to facilitate the introduction and positioning of an object therein) and a closure means thereof. Another embodiment features a flat sheet with a pocket at each end. Yet another embodiment simply is a sheet with adhesive on one surface at each end, such that the object to be covered (for example, an X-ray cassette, table or chair seat surface, etc.) is placed face down on the sheet (or vice versa) and the two ends are folded back to stick to the back side of the object. Another embodiment uses a bag folded back upon itself (prior to use) such that, once the object to be covered is inserted into the bag (and thereby is partially covered to the depth of that portion of the bag), the folded-over section is pulled over the remaining portion of the object, and closure is effected. This latter embodiment thereby provides the advantage of a potentially totally clean and initially sterile outer covering.
The closure means may be adhesive, as mentioned above, or, where one portion or flap of the back meets another for closure, heat sealing, Ziplock(trademark), folded flap, zipper, or hook-and-loop structures (such as Velcro(trademark)) may be utilized. In addition, xe2x80x9cprotectedxe2x80x9d adhesive closure means may be used where the adhesive area is covered with a removable strip until ready for closure.
Though the covers of the present invention are directed mainly to various medical, surgical and diagnostic apparatuses, they also apply to such areas as pillows and mattresses, faucet handles and other handles, table and chair seat surfaces, toilet seats, etc. Thus, by using the back-folded bag embodiment of the present invention, a pillow cover, for example, may be made that permits a patient to experience a totally clean surface on which to place his head or other body part.